SRL2011-570: In Vitro Evaluation of the Critical Wavelength of Sunscreen Products

Final Report January 5, 2012

Revised February 2, 2012

Objective: To evaluate the critical wavelength of sunscreenproducts after irradiation with a full spectrum UV dose of 4 MEDs (800 effective J/m2), according to the FDA Final Rule of June 17, 2011.

Test Product: SPF 30 Lip Balm (Wintermint) Formula

Results: The test product, SPF 30 Lip Balm (Wintermint) 39-62, had a

mean Critical Wavelength of 371 nm after a fullspectrum UV dose of 4 MEDs (800 effective J/m2), indicating that the formula meets the requirementsfor labeling as “Broad Spectrum” [1]

Sponsor: T’s Supergoop!e 43409

Holly Thaggard, CEO & Founder

Investigator: Joseph W. Stanfield, M. S. Investigator

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Suncare Research Laboratories, LLC SRL2011-570 2518-B Reynolda Road SPF 30 Lip Balm (Wintermint) Winston Salem, NC 27106 Formula (336) 725-6501 Supergoop! (336) 725-6503 fax FDA Final Rule Critical Wavelength

Revised February 2, 2012

Figure 2. Mean Percent Area under the Absorbance Curve between 290 and 400 nm after a Full-Spectrum UV Dose of 4 MEDs (800 effective J/m 2

)

Area

100%

90%

80%

70%

60% ra QJ.... 50%<C

....-.--...-..- --------.__.._ ._ ...._- -40%'* 30%

20%

10%

'-,""""""--'--r--'-r-,---,-- ---,------,0% 290 300 310 320 330 340 350 360 370 380 390 400

Wavelength (nm)

Conclusion: The mean Critical Wavelength was 371 nm (SD=O.OO, CV%=O.OO%) after a full-spectrum UV dose of 4 MEDs (800 effective J/m 2 ). The test product meets the requirements for labeling as "Broad Spectrum". [1]

..._.._ _... w. _ ...

........_......_.__.

------,--_._--,----

t??-ht 2c:?/Z Date

References: 1. Broad Spectrum Test Procedure, U.S. Food and Drug

Administration, 21 CFR Parts 201 and 310, Federal Register, Vol. 76, No. 117, Friday, June 17, 2011, pp. 35620-35665

2. Diffey BL. A method for broad spectrum classification of sunscreens. Int J Cosmet Sci 1994;16:47-52.

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SRL2011-570: Evaluation of the Static Sun Protection Factor (SPF) of Sunscreen-Containing Formulas According to the FDA Final Rule [1]

February 1, 2012 Revised February 2, 2012

Final Report Objective: To measure the static sun protection factor (SPF) of over-

the-counter (OTC) sunscreen-containing formulas according to the FDA Final Rule [1]

Test Product: SPF 30 Lip Balm (Wintermint) Formula Study Dates: January 10, 2012 to January 28, 2012 Results: Ten subjects completed the test. The mean static SPF of the

test product, SPF 30 Lip Balm (Wintermint) – Formula , was 32.84 (n=10,

SD=3.82). The test product meets FDA Final Rule requirements for labeling as Static SPF 30. [1]

Sponsor: T’s Supergoop! e 434 09 Holly Thaggard, CEO & Founder Investigator: Joseph W. Stanfield, M. S.

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Table 1. Subject Demographic and Static SPF Results for Lip Balm (Wintermint) ‐ Formula #  and 7% Padimate‐O/3% Oxybenzone Standard

Tech Initals Subject # SRL ID# Initials Age Sex Skin Type MEDuI (eff J/m2) MEDuR (eff J/m2) tpMEDp (eff J/m2) SPF ssMEDp (eff J/m2) SPFAOS 01 2758 CAP 28 M III 173.44 180.67 5200.67 28.79 2824.50 15.63AOS 02 2088 DLS 57 M III 242.22 308.00 9596.83 31.16 5216.11 16.94AOS 03 2381 KDB 57 F III 222.72 217.00 7684.22 35.41 4178.33 19.25

JL/EMA 04 2658 MEF 33 F II 190.22 184.89 6564.67 35.51 3567.78 19.30MPB 05 363 NOP 31 F II 223.78 230.00 5843.50 25.41 4200.50 18.26

AOS/MPB 06 1849 RAK 40 M III 179.17 179.44 6182.22 34.45 3354.67 18.69AOS 07 895 SGM 41 F I 94.22 91.67 2821.33 30.78 1771.78 19.33MPB 08 445 ESS 59 F II 175.11 136.67 5248.33 38.40 2481.11 18.15MPB 09 2815 KRS 19 F III 181.00 186.00 6243.72 33.57 3388.72 18.22MPB 10 2817 GWS 19 M II 178.00 175.67 6143.33 34.97 3335.56 18.99

Mean= 38.40 Mean= 32.84 18.28SD= 15.17 SD= 3.82 1.18

n= 10 n= 10 10SE= 1.21 0.37

t= 2.26 2.26Labeled SPF = 30 17

Mean: Valid (Y/N) YesLabeled: Valid (Y/N) Yes

Lip Balm (Wintermint) Formula

7% Padimate-O/3% Oxybenzone Standard

SRL2011-570: Supergoop!

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Suncare Research Laboratories, LLC SRL2011-570 2518-B Reynolda Road SPF 30 Lip Balm (Wintermint) Winston Salem, NC 27106 Formula (336) 725-6501 Supergoop! (336) 725-6503 fax FDA Final Rule Static SPF

Revised February 2, 2012

Adverse Events: No Adverse Events were reported.

Conclusion: The test product, SPF 30 Lip Balm - Formula

meets the FDA Final Rule requirements for labeling as Static SPF 30. [1] .

Date

1. U. S. Food and Drug Administration. Labeling and Effectiveness Testing; Sunscreen Drug Products for Over-the-Counter Human Use; Final Rule; 21 CFR Parts 201 and 310. Federal Register, Vol. 76, No. 117, June 17, 2011. pp.35660-35665.

2. Guideline for the colorimetric determination of skin color typing and prediction of the minimal erythema dose (rv'IED) without UV exposure. Colipa, 2007.

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